Iron Sucrose 100 mg/5mL
Iron Sucrose · INJECTION · Sandoz Inc
Iron Sucrose is a injection containing iron sucrose at 100 mg/5mL, taken intravenous. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Iron Sucrose
- Generic Name
- Iron Sucrose
- NDC Code (Product)
0781-3486- Manufacturer
- Sandoz Inc
- Strength
- 100 mg/5mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA212340
- Drug Class
- Parenteral Iron Replacement [EPC]
- Marketing Start
- 09/22/2025
Recall History
American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Infusion Options, Inc.
Lack of Assurance of Sterility
American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Population Dose Adult patients Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) ( 2.2 ) 100 mg slow intravenous injection or infusion Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) ( 2.3 ) 200 mg slow intravenous injection or infusion Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD) ( 2.4 ) 300 mg or 400 mg intravenous infusion Pediatric patients HDD-CKD ( 2.5 ), PDD-CKD or NDD-CKD ( 2.6 ) 0.5 mg/kg slow intravenous injection or infusion 2.1 Mode of Administration Administer iron sucrose injection only intravenously by slow injection or by infusion. The dosage of iron sucrose injection is expressed in mg of elemental iron. Each mL contains 20 mg of elemental iron. 2.2 Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD) Administer iron sucrose injection 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session [see How Supplied/Storage and Handling (16.2) ] . Administer iron sucrose injection early during the dialysis session (generally within th…
Contraindications
4 CONTRAINDICATIONS • Known hypersensitivity to iron sucrose. • Known hypersensitivity to iron sucrose. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Iron sucrose may reduce the absorption of concomitantly administered oral iron preparations.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Hypotension [see Warnings and Precautions (5.2) ] • Iron Overload [see Warnings and Precautions (5.3) ] • Adult patients: The most common adverse reactions (≥2%) are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain, and peripheral edema. ( 6.1 ) • Pediatric patients: The most common adverse reactions (≥2%) are headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, nausea, arteriovenous fistula thrombosis, hypotension, and hypertension. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice. Adverse Reactions in Adult Patients with CKD The…
Frequently Asked Questions
What is Iron Sucrose used for?
Iron Sucrose contains Iron Sucrose. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Iron Sucrose a controlled substance?
Iron Sucrose is not classified as a controlled substance by the DEA.
What is the generic name for Iron Sucrose?
The generic name for Iron Sucrose is Iron Sucrose. There are 4 other brand versions of Iron Sucrose.
What is the NDC code for Iron Sucrose 100 mg/5mL?
The NDC (National Drug Code) for Iron Sucrose 100 mg/5mL is 0781-3486, listed by Sandoz Inc.